BI Nutraceuticals has kicked-off a comprehensive education program designed to inform the dietary supplement industry about the FDA's ban on the use of both irradiation and ethylene oxide (ETO) as a means of sterilization for raw materials. As part of this initiative, BI has compiled a four-page consultative guide to help industry members better understand U.S. regulations surrounding the banned use of ETO and irradiation as a means for dietary supplement ingredient sterilization, as well as familiarize them with legal alternatives including steam sterilization.
BI utilized the FDA, American Herbal Products Association and Loren Israelsen, Director of the United Natural Products Alliance, to gather the most current information surrounding sterilization regulations. As additional educational components to this program, BI will speak on allowable sterilization methods at industry tradeshows including SupplyExpo in March, provide a copy of the guide to its current and potential customer base, as well as outreach to key industry media outlets to increase editorial coverage related this topic.
"What a majority of manufacturers in the industry may not realize that the use of ETO and irradiation for the purpose of reducing or eliminating microbial loads is not permitted right now," stated George Pontaikos, president and CEO, BI Nutraceuticals. "These restrictions are not part of the new cGMPs that are being phased in over a three-year period, they are being enforced currently and companies using ETO or irradiated materials are subject to FDA penalties now."
ETO is considered a pesticide, and according to the Federal Food, Drug and Cosmetic Act, any food that bears or contains a pesticide chemical residue that is unsafe is considered adulterated. In addition to being banned in the EU and numerous other countries, ETO is also included on California's Proposition 65 list of chemicals known to cause cancer or reproductive toxicity. In the preamble of the cGMPs, the FDA states that irradiation of dietary ingredients and dietary supplements as a means to reduce or eliminate microbial loads is not permitted. And like ETO, irradiation is also prohibited throughout Europe.
There are alternatives to these illegal and potential hazardous sterilization methods, including BI Nutraceuticals' GMP-compliant Protexx HP(R) system, which uses super-heated dry steam to reduce microbiological load, yielding results comparable to treating ingredients with ETO or irradiation, but without the potential regulatory issues. BI now has more than 700 species and genius specific computer protocols to systematically sterilize its vast catalogue of botanical ingredients. BI now has more than 700 species and genius specific computer protocols to systematically sterilize its vast catalogue of botanical ingredients. For the guide, see the attached PDF.